Course Overview

Decision Points PreviewThis introductory course focuses on the critical decisions made during a question-based label-driven approach to development of a pharmaceutical candidate from discovery through to product launch and marketing. The course highlights the decisions involved in the identification of a lead pharmaceutical candidate, conducting preclinical work to provide safety data to support the initial human clinical studies, establishing optimal therapeutic doses with an acceptable benefit-to-risk ratio, generating a label, and deciding to file an NDA or BLA. A key element of the module is a discussion of how the development of a pharmaceutical candidate is a stepwise approach of learning, confirming and affirming that together with the product label drives the pharmaceutical development process.

You should expect to spend approximately 6 hours of study time to complete the course.

Course Objectives

  • Understand the pharmaceutical development process
  • Describe each knowledge-based phase of the pharmaceutical development process
  • Understand the importance of, and differences between, Learning Studies and Confirming Studies
  • Define critical decision points in the pharmaceutical development process
  • Utilize the questions and critical decision points to design a pharmaceutical development plan

Who Should Attend

Individuals from any discipline new to drug development, including pharmacists.

  • History of Drug Regulation:  Who Regulates and Why Contemporary, Knowledge-Based Drug Development as Compared to the Traditional, Activity-Based Approach
  • Critical Drug Development and Review Decision Points
  • Successful and Failed Drug Development Programs
Continuing Education Credit
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for completion of this program. To receive credit, you must complete the entire program and submit the Continuing Education Application form directly to the PERI Registrar. Additional $35 fee applies for students who are applying for continuing education credit.

Continuing Pharmacy Education
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number is #0708-0000-15-008-H04-P; 0.6 continuing education units (CEU) are available for this program. Initial Release Date: 11/02/2015; Expiration Date: 11/02/2018. This is a knowledge based CPE activity.

Continuing Medical Education
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. PERI, Inc. designates this enduring material for a maximum of 6 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Minimum Computer Requirements
This web-based module requires a current browser version, such as Google Chrome, Internet Explorer, or Safari; Adobe Acrobat Reader and Flash plug-ins; and a reliable network connection.

PERI, Inc. is the sole owner of the information collected at various points on this site. We will not sell, share, or rent this information to others in ways different from what is disclosed in this statement.

Course Details

Online Course
2-Month Access
$450.00 Registration Fee

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Contact one of our course instructors to ask a specific question about the program.
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Our Students

  • 1 “The big picture about drug development will help me to design good clinical trials.”

  • 2 “This information will allow me to bring these principles back to my day-to-day drug development plan.”